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Microneedles for Diagnosis of LTBI

Pilot Study for Development of Microneedles for Diagnosis of Latent Tuberculosis Infection

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04552015
Enrollment
4
Registered
2020-09-17
Start date
2021-04-08
Completion date
2022-10-01
Last updated
2023-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Latent Tuberculosis

Brief summary

This study will evaluate new technique, microneedle, to detect latent tuberculosis (TB) in healthy volunteers

Detailed description

The cross-sectional study to investigate the effect of microneedle formulations and lengths of Tuberculin PPD microneedles on the delayed-type hypersensitivity response in healthy volunteers.

Interventions

DIAGNOSTIC_TESTTST vs PPD microneedle test

TST vs First patch: 800 um in length, PPD1 formulation; Second patch: 1,500 um in length, PPD1 formulation; Third patch: 800 um in length, PPD2 formulation; and Fourth patch: 1,500 um in length, PPD2 formulation

Sponsors

National Nanotechnology Center (NANOTEC), The National Science and Technology Development Agency (NSTDA)
CollaboratorUNKNOWN
The HIV Netherlands Australia Thailand Research Collaboration
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

1. Sex : Male and Female 2. Age : 20-60 years 3. TB contacts or those at risk of TB e.g. health-care workers 4. HIV-negative healthy individuals

Exclusion criteria

1. Presence of an acute infection, as determined by investigators 2. Receiving immunosuppression drugs e.g. steroids 3. Having autoimmune diseases e.g. SLE (Systemic Lupus Erythematous) 4. Being pregnant or breastfeeding

Design outcomes

Primary

MeasureTime frameDescription
size of induration at 48 hours post-PPD injection48 hoursMonitoring the response of delayed-type hypersensitivity on the skin by comparing TST to microneedle tests

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026